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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-25703-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion in the nsicu, resistance was met when inserting the guide wire. As a result, the guide wire was removed and found kinked. A new kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed. The customer returned one guide wire. Visual examination of the guide wire revealed four kinks at the distal end of the wire and the j- bend appeared typical. The four kinks were measured at 1. 3, 1. 9, 2. 1 and 2. 8 cm from the distal weld. Microscopic examination confirmed the four kinks and found that three kinks had offset coils. Microscopic examination also confirmed that both welds were full and spherical. A manual tug test confirmed that both welds remain intact. The guide wire measured approximately 601 mm in the total length and exhibited an outside diameter (od) measured 0. 804 mm. The returned guide wire was within specification for length and od per guide wire graphic (length: 596 - 604 mm and od: 0. 788- 0. 826mm). The instructions for use, describe suggested techniques to minimize the likelihood of guide wire damage during use. The device history record review was performed and did not reveal any manufacturing related issues. Since the guide wire is always inserted through another component such as an introducer needle, ars syringe, or introducer catheter and none other remarks: of these components were returned, the probable cause of this issue could not be determined. No further action will be taken.
 
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Brand NameCVC SET: 3-LUMEN 7 FR X 20 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5836253
MDR Text Key50821158
Report Number3006425876-2016-00197
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberCS-25703-E
Device Lot Number71F15J1990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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